Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

NCT ID: NCT00064220

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2005-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.

Detailed Description

OBJECTIVES:

• Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin.
• Determine the duration of response in patients treated with this drug.
• Determine the time to tumor progression in patients treated with this drug.
• Determine the median survival time and 12-month survival rate of patients treated with this drug.
• Determine the quantitative and qualitative toxic effects of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.

Conditions

Sarcoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

soblidotin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Gastrointestinal stromal tumor
• Chondrosarcoma
• Malignant mesothelioma
• Neuroblastoma
• Osteosarcoma
• Ewing's sarcoma
• Embryonal rhabdomyosarcoma
• Evidence of disease progression
• Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease

• Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy
• At least 1 measurable lesion with indicator lesions outside of any prior radiation field
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 15 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Bilirubin no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• Ejection fraction at least 40% by MUGA

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No baseline neurotoxicity grade 2 or greater
• No concurrent serious infection
• No psychiatric disorder that would preclude giving informed consent or complying with study requirements
• No other concurrent severe or uncontrolled medical illness that would preclude study participation
• No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy and recovered
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy
• No concurrent radiotherapy

• Localized radiotherapy to a non-indicator lesion for pain relief allowed provided all other methods of pain control are ineffective

Surgery

• At least 4 weeks since prior major surgery and recovered

Other

• At least 4 weeks since prior myelosuppressive therapy
• At least 4 weeks since prior investigational drugs
• No other concurrent investigational drugs
• No other concurrent anticancer cytotoxic therapy

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Pagan

Role: STUDY_CHAIR

Daiichi Sankyo

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Veterans Affairs Medical Center - San Juan

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Patel S, Keohan ML, Saif MW, Rushing D, Baez L, Feit K, DeJager R, Anderson S. Phase II study of intravenous TZT-1027 in patients with advanced or metastatic soft-tissue sarcomas with prior exposure to anthracycline-based chemotherapy. Cancer. 2006 Dec 15;107(12):2881-7. doi: 10.1002/cncr.22334.

Reference Type: RESULT

PMID: 17109446 (View on PubMed)

Other Identifiers

DAIICHI-1027A-PRT007

Identifier Type: -

Identifier Source: secondary_id

CPMC-IRB-20030512

Identifier Type: -

Identifier Source: secondary_id

MSKCC-03061

Identifier Type: -

Identifier Source: secondary_id

CDR0000310138

Identifier Type: -

Identifier Source: org_study_id